SEFRIA Hydrocodone Oral Fluid
FDA 510(k) K252520 · Immunalysis Corporation
510(k) numberK252520
Submission
- Device name
- SEFRIA Hydrocodone Oral Fluid
- Applicant
- Immunalysis Corporation
Pomona, CA, US - Received
- August 11, 2025
- Decision date
- September 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette)…DJG · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/09/2024SE |
More from Hangzhou Laihe Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232898 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 11/21/2023SE |
| K223781 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/28/2023SE |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | 12/22/2021SE |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayDJG · Traditional | 12/22/2021SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 04/20/2021SE |
| K200801 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 07/28/2020SE |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK · Traditional | 11/15/2019SE |
| K183048 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/29/2019SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 01/24/2019SE |
| K181553 | Immunalysis Ethyl Alcohol Enzyme AssayDIC · Traditional | 10/31/2018SE |
Questions and answers
When was SEFRIA Hydrocodone Oral Fluid cleared by the FDA?
SEFRIA Hydrocodone Oral Fluid (K252520) received a 510(k) decision of Substantially Equivalent on September 11, 2025, 31 days after the submission was received.
What is the product code of K252520?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.